This Core will provide technical support and counsel in all of the considerations for applying statistics to meet Project objectives. This Core will provide the randomizations for the clinical trials, maintain a data base of results, perform statistical analyses, perform statistical quality control of data items and conduct special statistical studies to support the research agenda. In addition, this Core will introduce state- of-the-art, recently developed statistical methods where appropriate, and work on developing new statistical methodologies to more effectively analyze Project data.